At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
Regulatory Partner
At Roche, our mission is to deliver innovative medicines and services that truly make a difference for patients. This senior-level opportunity as a Regulatory Partner puts you at the heart of that mission, where you will implement registration strategies through hands-on operational work, ensure compliance while supporting patient access to the newest therapies and beyond-the-product services, and contribute your expertise to inform business strategy with up-to-date regulatory insights and guidance for smooth product or device launches. You will also coordinate, supervise, and drive initiatives within your area of responsibility, making a tangible impact on both projects and patient outcomes.
We offer a hybrid work model that combines flexibility with in-person collaboration. For now, we require our employees to be in our office in Warsaw on average two days per week. The specific office days may vary depending on business needs, such as workshops, conferences, town halls, team meetings, and other collaborative events.
The opportunity:
Work with the global team to secure new Marketing Authorizations locally and fulfill all obligations of the Marketing Authorization Holder and/or its affiliate after authorization, in line with pharmaceutical law and internal procedures (local and global).
Build and maintain strong relationships with key institutions – URPL, GIF, MZ, and industry associations such as INFARMA – to influence registration processes, support early advocacy, co-create industry solutions, and shape the regulatory environment.
Ensure doctors, pharmacists, and patients receive the information needed for safe medicine use (e.g., Risk Management Plan, DHPC letters).
Review promotional and informational materials for compliance, manage the abbreviated Summary of Product Characteristics.
Provide stakeholders with timely regulatory updates and intelligence to support activity prioritization, product development, clinical trials, documentation needs, and awareness of major regulatory changes.
Secure audit readiness by applying the “right first time” principle across all audited activities.
Manage registration documentation: ensure proper circulation, timely submission to authorities, and systematic archiving.
Who you are:
Higher medical, pharmaceutical, or related education.
At least 3 years of experience in the pharmaceutical industry
English language proficiency at least at B2 level.
Possesses knowledge regarding GxP (GVP, GCP) and uses it during daily activities.
Proficient in medical and registration terminology and understands the medicinal product lifecycle.
What you get:
Competitive salary based on the employment contract (Umowa o pracę),
Annual bonus payment based on your performance.
Dedicated training budget (training, certifications, conferences, diversified career paths etc.).
Recharge Fridays (2 Fridays off per quarter available).
Take time Program (up to 3 months of leave to use for any purpose).
Vacation subsidy available.
Flex Location (possibility to perform our work from different places in the world for a certain period of time).
Take Time for Charity (additional paid leave of maximum 2 weeks to engage in the charity action of your choice).
Private healthcare (LuxMed packages), group life insurance (UNUM) and Multisport.
Stock share purchase additions.
Yearly sales of company laptops and cars and many more!
Apply directly and join us in shaping the future of healthcare.
If you feel this offer suits a friend of yours, feel free to share it.
The controller of your personal data is Roche Polska Sp. z o.o., ul. Domaniewska 28, 02-672 Warsaw. The data is processed for the purpose of recruitment. You have the right to access your data, rectify it, delete it, limit processing, transfer it and - if processing is based on your consent - withdraw this consent at any time. Contact the Data Protection Officer at: Ochrona.danych@roche.com. More information on the principles of processing your personal data by Roche at the link:
https://www.roche.pl/pl/content/klauzula-informacyjna-rekrutacja-en.html
Roche Polska sp. z o.o. operates in full compliance with the law and does not tolerate any violations. Roche Polska sp. z o.o. has implemented a Procedure for Reporting Violations of Law. If you wish to report any irregularities related to our activities, all necessary information regarding the reporting process can be found on our website: https://www.roche.pl/kontakt/ochrona-sygnalistow-zglaszanie-naruszen.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.